ChitoCare Medical Wound Healing Gel PMCF Study on Healing of Chronic Wounds

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-11

Study Completion Date

2024-10-15

Brief Summary

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We are testing a gel intended for the protection and healing of chronic wounds as a support for standard therapy. The main component of the gel is chitosan, a natural polymer that has the ability to stop bleeding, has a positive effect on wound healing, and has antimicrobial properties.

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Detailed Description

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The purpose of this PMCF study is to evaluate the safety and efficacy of ChitoCare medical Wound Healing Gel for the healing of chronic wounds. The study will enroll patients with diabetic foot ulcer, venous ulcer or pressure ulcer. Patients will be randomly assigned to an active or control group. The active group will apply the gel to the wound, in addition to the standard of care, while the control group will receive only standard care. The study will last from 3 to 18 months for an individual patient (15-month recruitment period and 3 months of follow-up after the last patient is enrolled) or until event occurrence (complete wound healing/exclusion from the study). The study envisages four visits: Visit 1 - Screening and Inclusion visit, Visit 2 (after 4 weeks), Visit 3 (after 12 weeks) and Visit 4 - End of Study Visit: The final visit will take place when the event occurs (complete healing/exclusion from study). On each visit, the patients will have their wound photographed and assessed after debridement. Adverse events will be followed throughout the whole study.

Conditions

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Diabetic Foot Ulcer Venous Leg Ulcer Pressure Ulcer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Active group

Active group will apply ChitoCare medical Wound Healing Gel to the wound in addition to standard of care.

Group Type EXPERIMENTAL

ChitoCare medical Wound Healing Gel

Intervention Type DEVICE

ChitoCare medical Wound Healing Gel is a CE-marked medical device.

Control group

Control group will only administer standard of care to treat their wounds.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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ChitoCare medical Wound Healing Gel

ChitoCare medical Wound Healing Gel is a CE-marked medical device.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Written informed consent must be given
2. Patient ≥ 18 years old
3. Presence of chronic wound (Wagner grade I and II diabetic foot ulcer, venous leg ulcer or pressure ulcer) that meets the following criteria:

* Size of the wound ≥ 0.5 cm2
* Wound is not infected at the time of randomization
* Wound is present for at least 4 weeks
4. Able to understand and comply with the requirements of the study

Exclusion Criteria

1. Patients with serious concomitant disease (cancer, heart failure (NYHA class IV), severe anaemia (Hb\<100 g/L), neoplasia)
2. Any significant condition that may preclude the participant from the study (e.g. severe depression or psychiatric illness)
3. Patients that will require surgical procedure to treat their ischemic condition on the limb where the wound is present as assessed by the investigator
4. Patients diagnosed with autoimmune connective tissue diseases
5. Previous treatment under this clinical protocol
6. Participation in another clinical trial
7. Receiving or scheduled to receive a medication or treatment which, in the opinion of the investigator, was known to interfere with, or affect the rate and quality of wound healing
8. Allergy to shellfish (for active study group)
9. Medical condition likely to require systemic corticosteroids during the study period
10. Pregnant and lactating women

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No